Formulation and characterisation of a self-nanoemulsifying drug delivery system of amphotericin B for the treatment of leishmaniasis

This study was aimed to develop a self-nanoemulsifying drug delivery system (SNEDDS) for amphotericin B (AmB) potential use in leishmaniasis through topical and oral routes. Two formulations, formulation A and formulation B (FA and FB) of AmB loaded SNEDDS were developed by mixing their excipients through vortex and sonication. The SNEDDS formulation FA and FB displayed a mean droplet size of 27.70 +/- 0.5 and 30.17 +/- 0.7 nm and zeta potential -11.4 +/- 3.25 and -13.6 +/- 2.75 mV, respectively. The mucus permeation study showed that formulation FA and FB diffused 1.45 and 1.37%, respectively in up to 8 mm of mucus. The cell permeation across Caco-2 cells monolayer was 10 and 11%, respectively. Viability of Caco-2 cells was 89% for FA and 86.9% for FB. The anti-leishmanial activities of FA in terms of IC50 were 0.017 mu g/ml against promastigotes and 0.025 mu g/ml against amastigotes, while IC50 values of FB were 0.031 and 0.056 mu g/ml, respectively. FA and FB killed macrophage harboured Leishmania parasites in a dose-dependent manner and a concentration of 0.1 mu g/ml killed 100% of the parasites. These formulations have the potential to provide a promising tool for AmB use through oral and topical routes in leishmaniasis therapy.